BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610. Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.

    Recall: Z-2033-2012 · Reported July 25, 2012

    Enforcement

    Recall Number
    Z-2033-2012
    Event ID
    61723
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2012
    Initiation Date
    January 13, 2012
    Classification Date
    July 19, 2012
    Termination Date
    July 29, 2013
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611, United States

    Description

    Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610. Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.

    Reason

    Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head.

    Code Info

    Class I; 510(k) Exempt Description: AVS¿ Navigator Trials. Size 6mm -15mm. Catalog Number: 48392206,48392207,48392208,48392209,48392210, 48392211,48392212,48392213,48392214,48392215. Lot Code: 104864,104866, 104867, 104868, 104869, 104870, 10E331, 104871, 104872, 104873, 104874, 104875.

    Distribution

    Nationwide.

    Quantity

    273 units